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Generic Version of Zonegran Passes FDA Muster
December 23, 2005
PITTSBURGH, Dec. 23 /PRNewswire-FirstCall/ -- Mylan Laboratories Inc. (NYSE:MYL) today announced that Mylan Pharmaceuticals Inc. has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Zonisamide Capsules, 25 mg, 50 mg, and 100 mg. Zonisamide Capsules are the AB-rated generic equivalent of Dainippon Pharmaceutical's Zonegran(R) Capsules, which had U.S. sales of approximately $171 million for the 12-month period ending June 30, 2005, according to IMS Health.
This product will begin shipping immediately.
Source: The Food and Drug Administration
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